Singapore clinches WHO’s top medical device classification

International experts validate Singapore device regulation system.

Singapore's Health Sciences Authority (HSA) reached Maturity Level 4 (ML4) for medical device regulation, making it the first World Health Organisation (WHO) Member State to achieve this classification, according to a press release.

The status indicates the national system for medical devices is quality-assured. Medical devices under this regulation include thermometers, blood pressure monitors, diagnostic tests, and surgical tools.

A team of international experts assessed the HSA in February 2026 using the WHO benchmarking framework, which includes over 260 indicators.

These metrics cover product registration, market authorisation, laboratory testing, post-market surveillance, and clinical trials oversight.

Raymond Chua, Chief Executive Officer of the HSA, said the classification reflects the effort to build a regulatory system that protects patients and enables access to health products.

He added that the HSA will work with the WHO and partners to support regulatory capacity building.

The HSA also maintains ML4 status for medicines and acts as a Stringent Regulatory Authority for high-risk in-vitro diagnostics, following the 2023 designation of the HSA as a WHO-Listed Authority.

Rabindra Abeyasinghe, WHO Representative to Malaysia, Brunei Darussalam, and Singapore, said the achievement reflects the commitment to regulatory systems to support access to health products and patient safety.

The regulatory system prevents the use of substandard and falsified products whilst enabling procurement and regional collaboration.

The assessment supports improvement of national systems in the Western Pacific Region and the world.